Beckman Coulter Delays FDA Filings For Key Heart Test To 3Q

Date : 04/18/2011 @ 11:54AM
Source : Dow Jones News
Stock : Beckman Coulter, Inc. (BEC)
Quote : 83.47  0.0 (0.00%) @ 2:05AM

Beckman Coulter Delays FDA Filings For Key Heart Test To 3Q

Beckman Coulter (NYSE:BEC)
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Beckman Coulter Inc. (BEC) has pushed back the timeline for two important U.S. regulatory filings, which the company needs to clear a test for heart problems it recalled last year, to the third quarter.

The company had long maintained that it expected to file Food and Drug Administration applications for the so-called troponin test in the first half this year. But citing progress in an ongoing clinical trial, talks with the FDA plus internal compliance and quality efforts, the company disclosed a delay to that timeline in a filing with the Securities and Exchange Commission Monday.

Beckman is filing two applications two cover the test's use with different systems.

The Orange County, Calif., company recalled the test in question, which measures a protein that signals heart problems, due to faulty results. Beckman last year also came under fire from the FDA, which believed the company marketed that test without the needed agency clearance.

Danaher Corp. (DHR), which is buying Beckman for $5.87 billion, has said that Beckman's heart-test issues were a key area of focus. Danaher Chief Executive H. Lawrence Culp Jr. said in February that the test could get back on the market by year-end, although he also said Danaher has "allowed ourselves a little bit of wiggle room."

A Danaher spokesman could not be reached for immediate comment Monday. The company in late March said it was extending its tender offer to acquire all outstanding Beckman shares to April 27.

Beckman shares recently traded down 18 cents to $82.97, near the planned take-over price of $83.50 per share. Danaher shares were recently down 2.6% to $51.35.

-By Jon Kamp, Dow Jones Newswires; 617-654-6728; jon.kamp@dowjones.com

 
 



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